BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3955416 · Received June 12, 2014

    Report

    Report Number
    9615050-2014-03962
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    April 4, 2014
    Report Date
    May 20, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED. DURING A REVIEW OF THE DEVICE HISTORY TOUCHSCREEN FAIL AND INVALID ID ERRORS WERE NOTED. FURTHER TESTING FOUND CORROSION ON THE TOUCHSCREEN. THE PROBABLE CAUSE THE TOUCHSCREEN NOT RESPONDING WAS CORROSION DUE TO CONTAMINATION FROM FLUID INGRESS. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY THE DEVICE TOUCHSCREEN WAS NOT WORKING AND WOULD NOT CALIBRATE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347674 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1